Method of administering 5-aminolevulinic acid (ALA) to a patient

ABSTRACT

A method of administering 5-aminolevulinic acid (ALA) to a patient uses an adjustable illuminator for photodynamically diagnosing or treating a surface and which includes a plurality of first panels and at least one second panel. The plurality of first panels have wider widths and the at least one second panel has a narrower width. The narrower width is less than the wider widths. The illuminator further includes a plurality of light sources, each mounted to one of the plurality of first panels or the at least one second panel and configured to irradiate the surface with substantially uniform intensity visible light. The plurality of first panels and the at least one second panel are rotatably connected. The at least one second panel is connected on each side to one of the plurality of first panels. The second panel acts as a “lighted hinge” to reduce or eliminate optical dead spaces between adjacent panels when the illuminator is bent into a certain configuration.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/791,004, filed Feb. 14, 2020, which is a divisional application ofU.S. application Ser. No. 15/292,731, which was filed Oct. 13, 2016 andgranted as U.S. Pat. No. 10,589,122 on Mar. 17, 2020, which claims thebenefit of priority to U.S. Provisional Application No. 62/241,902 filedon Oct. 15, 2015, the entire contents of all of which are incorporatedherein by reference.

FIELD

The invention relates generally to an adjustable illuminator thatprovides a uniform distribution of visible light in a number ofconfigurations and is suitable for use in photodynamic therapy anddiagnosis.

BACKGROUND

Photodynamic therapy (PDT), photodynamic diagnosis (PD), orphotochemotherapy is generally used to treat and/or diagnose severaltypes of ailments in or near the skin or other tissues, such as those ina body cavity. For example, PDT or PD may be used for treatment ordiagnosis of actinic keratosis of the scalp or facial areas of apatient. In addition, PDT and PD may be used for treatment and diagnosisof other indications (e.g., acne, warts, psoriasis, photo-damaged skin,cancer) and other areas of the patient (e.g., arms, legs).

During one form of PDT or PD, a patient is first administered aphotoactivatable agent or a precursor of a photoactivatable agent thataccumulates in the tissue to be treated or diagnosed. The area in whichthe photoactivatable agent is administered is then exposed to visiblelight, which causes chemical and/or biological changes in the agent.These changes allow the agent to then selectively locate, destroy, oralter the target tissue while, at the same time, causing only mild andreversible damage to other tissues in the treatment area. One example ofa precursor of a photoactivatable agent is 5-aminolevulinic acid(“ALA”), which is commonly used in PDT of actinic keratosis. As they areused here, the terms ALA or 5-aminolevulinic acid refer to ALA itself,precursors thereof and pharmaceutically acceptable salts of the same.

For effective treatment, it is desirable to have a power output that isuniform in intensity and color. Illuminators, such as those disclosed inU.S. Pat. Nos. 8,758,418; 8,216,289; 8,030,836; 7,723,910; 7,190,109;6,709,446; 6,223,071, which are incorporated by reference in theirentireties for the techniques, methods, compositions, and devicesrelated to PDT and PD, are typically used to provide the properuniformity of light for treatment purposes. These devices generallyinclude a light source (e.g., a fluorescent tube), coupling elementsthat direct, filter or otherwise conduct emitted light so that itarrives at its intended target in a usable form, and a control systemthat starts and stops the production of light when necessary.

SUMMARY

Because PDT can be used to treat a variety of treatment areas, someilluminators utilize two or more panels, each panel having a lightsource to emit light at the intended target area. These panels arecoupled together so as to be rotatable relative to each other. Byincorporating multiple, rotatable panels, the overall size and shape ofthe area that is illuminated can be changed according to the intendedtreatment area.

In conventional adjustable illuminators, the panels are equally sized bywidth and length and are typically driven at the same power level. Thepanels are further joined at their edges by hinges so as to be rotatableto achieve a desired configuration. However, due to the edges of thepanels and the presence of the hinges, the light source(s) of one paneldoes not immediately adjoin the light source(s) of an adjacent panel. Asa result, light is not emitted from a “gap” between the light sources.The lack of light emitting from such areas, together with the uniformsupply of power to the panels, can cause optical “dead space” in certainportions of the target treatment area. These portions, in turn, receiveless overall light, resulting in a lower dose of treatment in thoseportions. In some instances, the dose of treatment can be lowered by asmuch as a factor of five when compared with those areas receiving anoptimal amount of light.

Generally, these conventional illuminators are used for phototherapy ofacne, which typically does not require the administration of aphotoactivatable agent for effective treatment. Thus, exposure to thelight alone is generally sufficient treatment. Moreover, becausemultiple treatment sessions can be utilized to effectively treat thecondition, uniformity of light across the target area during a giventreatment is less of a concern in some situations. However, some formsof treatment involving PDT, such as the use of ALA to treat actinickeratosis, require specific and highly uniform intensity and color oflight to achieve effectiveness. In these instances, successful PDTrelies on the targeted delivery of both the correct quantity of thephotoactivatable agent and the correct quantity (i.e., power andwavelength) of light to produce the desired photochemical reactions inthe target cells. Thus, to achieve this, the light source must provideillumination to the target area and this illumination must be uniformwith respect to both wavelength and power. The optical dead space thatcan occur at or near the hinges of conventional adjustable illuminatorsreduces the uniformity of the light along the treatment area, therebyreducing the effectiveness of PDT for these specific treatments.Moreover, these illuminators are also configured to adjust within alimited range, such that only a limited amount of surfaces on apatient's body may be treated, such as a patient's face and scalp. Inaddition, due to the various contours of a patient's body, theuniformity of light delivered by these conventional illuminators mayvary substantially depending on the treatment area of the patient.

Therefore, it is an object of some embodiments of the present inventionto reduce or eliminate these dead spaces and provide for a more uniformlight distribution in an adjustable illuminator designed for PDT or PDof a variety of targeted areas. In addition, it is an object of someembodiments of the present invention to provide an infinitely adjustableilluminator that can effectively deliver a uniformity of light acrossvarious areas of a patient's body, such as a patient's extremities(e.g., arms and legs) or torso, in addition to a patient's face andscalp. Thus, a uniform light may be delivered to a targeted treatmentarea regardless of the shape and location of the contoured surface ofthe patient's body.

One embodiment of the present invention uses a plurality of panels,wherein at least one panel is of a different width than the otherpanels. This panel is positioned between two other panels and, in a way,acts as a “lighted hinge” to provide enough “fill-in” light to reduce oreliminate the optical dead spaces when the panels are bent into acertain configuration. Preferably, five panels in total are used toprovide for an optimal increase in the total size of possible treatmentareas. Two of the panels are preferably of a smaller width than theother three larger panels. These panels are positioned in an alternatingmanner such that each of the smaller-width panels is situated in betweentwo of the three larger panels to allow for both adjustability andincreased uniformity. Furthermore, to further reduce or eliminateoptical dead spaces, the panels are preferably coupled together usingnested hinges, thereby reducing the area in which no light source ispresent on the illuminator. In order to even further reduce or eliminateoptical dead spaces, it is preferable that the light sources on each ofthe panels are individually configurable to provide specific poweroutput to certain areas of the light sources on the panels to compensatefor decreased uniformity. For example, the power outputted to eachindividual diode in an array of light emitting diodes (LED) may beindividually adjusted.

BRIEF DESCRIPTION OF THE DRAWINGS

Features, aspects, and advantages of the present invention will becomeapparent from the following description and the accompanying exemplaryembodiments shown in the drawings, which are briefly described below.

FIGS. 1A-1B show top views of a main body of an illuminator according toan exemplary embodiment.

FIGS. 2A-2B show perspective views of the main body of the illuminatorof FIGS. 1A-1B.

FIGS. 3A-3B show detailed views of the nested hinges of the main body ofthe illuminator of FIGS. 1A-1B.

FIG. 4 shows a perspective view of the illuminator having the main bodyof FIGS. 1A-1B mounted to a stand.

FIG. 5 shows a schematic view illustrating an addressable configurationof LEDs mounted on the main body of the illuminator of FIGS. 1A-1B.

FIG. 6 shows a schematic view illustrating widths and lengths ofindividual panels of the main body of the illuminator of FIGS. 1A-1B.

FIG. 7 shows a graph illustrating light dosage across a treatment areaaccording to a conventional paneled illuminator.

FIG. 8 shows a graph illustrating light dosage across the same treatmentarea as FIG. 7 using an illuminator according to one embodiment of thepresent invention.

DETAILED DESCRIPTION

FIGS. 1A-1B and 2A-2B illustrate one embodiment of a configurableilluminator according to the present invention. The illuminator includesa main body 100, which preferably has five individual panels 10 a-10 e,each of which are connected in a rotatable manner via nested hinges 50.Each panel contains an array of light emitting diodes (LED) 60, whichmay be configured in an evenly spaced pattern across the face of thepanel. The number of individual LEDs arranged in a given array is notparticularly limited. Alternatively, other types of light sources may beused, such as fluorescent or halogen lamps.

Preferably, each LED array 60 extends as far to the edges as possible.In addition, the LED arrays 60 are preferably dimensioned to provide anoverall lighted area for a given treatment area based on a range fromthe 5th percentile of corresponding female sizes to the 95th percentileof corresponding male sizes for that particular treatment area. The LEDarrays 60 emit light at an appropriate wavelength according to theintended treatment or to activate the particular photoactivatable agentused in treatment or diagnosis. For example, when ALA is used as aprecursor of a photoactivatable agent for the treatment of actinickeratosis, the LED arrays 60 preferably emit blue light havingwavelengths at or above 400 nanometers (nm), for example, about 430 nm,about 420 nm or, for example, 417 nm. However, the LED arrays 60 mayalso emit visible light in other ranges of the spectrum, such as in thegreen and/or red ranges between 400 and 700 nm, for example, about 625nm to 640 nm or, for example, 635 nm. For example, the LED arrays 60 mayalso emit light having wavelengths of 510 nm, 540 nm, 575 nm, 630 nm, or635 nm. In addition, the LED arrays 60 may be configured to emit lightcontinuously or the LED arrays 60 may be configured to flash the diodeson and off based on a predetermined interval. Furthermore, the LEDarrays 60 may be configured such that only one wavelength of light(e.g., blue) is emitted. Alternatively, the LED arrays 60 may beconfigured such that two or more wavelengths of light are emitted fromthe arrays. For example, the LED arrays 60 may be configured toalternately emit blue light and red light for treatment purposes.

As shown in FIGS. 1A-1B and 2A-2B, the five panels 10 a-10 e are ofdifferent widths relative to one another. In particular, in certainembodiments, three panels 10 a, 10 c, 10 e are configured to have widerwidths, while two panels 10 b, 10 d have smaller, narrower widths, eachof the narrower widths of the two panels 10 b, 10 d being less than eachof the wider widths of the three panels 10 a, 10 c, 10 e. In someembodiments, the wider widths of the three larger panels 10 a, 10 c, 10e are approximately equal. In other embodiments, the wider widths of thethree larger panels 10 a, 10 c, 10 e are different relative to oneanother. In addition, the narrower widths of the two panels 10 b, 10 dmay be approximately equal or may be different relative to one another.The panels are further arranged in an alternating configuration, withthe narrower panels (e.g., 10 b) positioned in between two wider panels(e.g., 10 a, 10 c). As shown in FIG. 6, in some embodiments, thenarrower panels 10 b, 10 d are configured to have a width that is about30% to 60% less than the width of the wider panels 10 a, 10 c, 10 e. Inother embodiments, the narrower panels 10 b, 10 d are configured to havea width that is about 30% to 50% less than the width of the wider panels10 a, 10 c, 10 e.

As shown in FIGS. 1A-1B and 2A-2B, the panels 10 a-10 e are rotatablyconnected by hinges 50. The hinges 50 may take the form of nestedhinges, which may include hinges that substantially reduce or eliminateoptical dead spaces. As shown in FIGS. 2A-2B, on at least one side of apanel, a tab 23 may extend out from both the top and bottom of thepanel. The tabs 23 are configured such that a side of an adjacent panelmay be received between the tabs 23, as shown in FIG. 2A. Thus, as bestseen in FIGS. 2A-2B and 6, the height of the adjacent panel (e.g., panel10 a) is slightly smaller than the height of the tabbed panel (e.g.,panel 10 b) into which the adjacent panel is received. As shown in FIG.6, the middle panel (i.e., panel 10 c) is preferably configured ashaving the largest height, such that it is tabbed on both sides and mayreceive the sides of adjacent panels on each side. As seen in FIGS.1A-1B, each of the tabs 23 further includes an opening to receive a boltto connect adjacent panels together.

As shown in further detail in FIGS. 3A-3B, between the tabs 23 are thenested hinges 50, which are mounted to the inner side surfaces ofadjacent panels (e.g., 10 a, 10 b) to allow for rotation of the panels.A flange 51 of the hinge 50 is mounted to the inner side surface of apanel via bolts 53. The inner side surface of a panel may include arecess in which the flange 51 may be placed. The inner side surface ofthe panel may also include an additional recess to accommodate the jointof the hinge 50 such that the joint of the hinge 50 becomessubstantially flush with an outer front surface of the panel. Suchconfigurations may allow for the outside vertical edges of adjoiningpanels to be positioned closer to one another. By spacing the verticaledges of adjoining panels closer, optical dead spaces may be furtherreduced or eliminated. In addition, the hinges 50 together with the tabs23 may reduce the number of pinch points present in the system.

As shown in FIGS. 1A-1B, the main body 100 of the illuminator mayinclude a mounting head 40. The mounting head 40 may allow for the mainbody 100 to be mounted to a movable stand 80, which is shown in FIG. 4,to allow a user to easily move the main body 100 to the appropriatetreatment position. The stand 80 includes a base 81 and a verticalpillar 82. The base 81 may further include wheels 87 at its bottom inorder to allow the user to horizontally move the illuminator to anappropriate position. The wheels 87 may include locks, such that thestand 80 is prevented from further horizontal movement once positioned.In addition, the vertical pillar 82 may be attached to the base 81 at apivot point 83. The pivot point 83 allows the vertical pillar 82 to berotated to increase the range of positioning for the illuminator. At atop end, the vertical pillar 82 includes a connecting arm 85, which mayserve as a mounting structure for the main body 100. The connecting arm85 includes a hinge point 86 such that the main body 100 can be movedvertically relative to the stand 80. The vertical pillar 82 may also beconfigured as a telescopic structure, such that the user can change theheight of the vertical pillar 82. This allows for an increased range ofvertical movement for the main body 100, which can allow the user toposition the main body 100 at lower portions of a treatment area, suchas a patient's legs or feet. The stand 80 may also include astabilization arm 84. Once the stand 80 and main body 100 is positioned,the stabilization arm 84 may be attached to the main body 100 to preventunwanted movement of the main body 100 during treatment. As furthershown in FIG. 4, a controller and power supply 90 is mounted to thestand 80 in order to supply electrical power to the main body 100 andallow the user to control the main body 100 for treatment purposes.Alternatively, the controller and power supply 90 may be directlymounted to the main body 100. In order to provide a cooling system forthe LED arrays 60, one or more fans 70 may be mounted onto each of thepanels, as shown in FIG. 4.

At least one control unit is also connected to the panels to regulatepower to the lights to achieve the required uniformity and intensity forthe target treatment. The control unit may be implemented as hardware,software, or a combination of both, such as a memory device storing acomputer program and a processor to execute the program. Alternatively,each panel may have a dedicated control unit to regulate power to theindividual LED array on a given panel to allow for more particularfine-tuning of the illuminator, which may further enhance uniformity andincrease efficiency. For example, under Lambert's cosine law, lightintensity at a given point on a “Lambertian” surface (such as skin) isdirectly proportional to the cosine of the angle between the incomingray of light and the normal to the surface. Thus, a ray of light that isdirected to the front of a curved surface (e.g., a head of a patient)will arrive in a substantially perpendicular manner to that area andwill result in 100% absorbance. However, a ray of light that arrives ata side edge of the curved surface will arrive in a substantiallyparallel manner. According to Lambert's cosine law, the intensity, andthus absorption, of the light at the side edge will approach zero,making treatment at that area ineffective. Thus, a “fall off” of lightexposure tends to occur at the edges of a curved surface. In addition,“fall off” increases as the distance between the light source and thepoint on the surface increases.

Configuring an illuminator to conform to the curved surface (e.g., aU-shaped configuration designed to “wrap around” the curvature of thesurface) aids in reducing this effect and increases overall uniformity.However, to sufficiently increase uniformity, the light source should belarger relative to the target treatment area in order to fully encompassthe body part to be treated and also provide light from all angles toany target point on the treatment area. In order to increase theuniformity of light exposure to the treatment area while maintaining apractical size of the illuminator, the LED arrays 60 may be individuallyconfigured to increase the intensity of light emitting from certaindiodes to compensate for this fall-off effect.

An example in which the LED arrays 60 may be individually configured isshown in FIG. 5. Here, the LED arrays 60 are divided into three generalareas, which may be described as “addressable strings.” Areas 1, 3, and5 correspond to an addressable string configuration that may be includedin the wider panels 10 a, 10 c, and 10 e, while areas 2, 4, and 6correspond to an addressable string configuration that may be includedin the narrower panels 10 b and 10 d. The current to each area isadjusted in order to adjust the intensity of light emitting from each ofthe areas. For example, a higher current may be supplied to areas 1 and2 than the current supplied to areas 3 and 4 such that areas 1 and 2emit a higher intensity of light than areas 3 and 4. Similarly, a highercurrent may be supplied to areas 3 and 4 than the current supplied toareas 5 and 6. Thus, a higher intensity of light is emitted overall fromthe edges, which may allow for a reduction in any fall-off effect.Alternatively, the illuminator may be configured to adjust eachindividual diode present in a given LED array 60, allowing for an evengreater fine-tuning effect. Furthermore, by using either pre-programmedsettings or sensors to detect the curvature of the surface to betreated, the LED arrays 60 can be individually configured to emit moreintense light to only those areas that require it. This allows for anincrease in uniformity of light exposure in an efficient manner as poweroutput and/or light intensity is increased to only certain diodes, inaccordance with need.

The addressable strings of the LED arrays 60 may also include varyingamounts of individual diodes mounted within the particular area. Forexample, for the wider panels 10 a, 10 c, and 10 e, 12 diodes may bemounted in each of areas 1, while 9 diodes may be mounted in each ofareas 3 and 41 diodes may be mounted in area 5, resulting in a total of83 individual diodes included within each of the wider panels 10 a, 10c, and 10 e. For the narrower panels 10 b and 10 d, 8 diodes may bemounted in each of areas 2, while 9 diodes may be mounted in each ofareas 4, and 23 diodes may be mounted in area 6, resulting in a total of57 individual diodes included within each of the narrower panels 10 band 10 d. However, the number and arrangement of diodes included withineach of the LED arrays 60 is not particularly limited. For example, thewider panels 10 a, 10 c, and 10 e may each contain a total amount ofdiodes that ranges from about 80 diodes to about 350 diodes. Similarly,the narrower panels 10 b and 10 d may each contain a total amount ofdiodes that ranges from about 50 diodes to about 250 diodes. By varyingthe arrangement of the diodes within each of the addressable strings ofthe LED arrays 60, power output and/or the intensity of light emittedfrom a given array may be better controlled and fine-tuned.

In addition, individually regulating power to the LED arrays 60 can alsocontribute to the reduction or elimination of the optical dead spacesthat may otherwise occur at the hinge points. Specifically, power outputand/or the emitted light intensity may be increased close to the edgesof the array that are closest to the nested hinges to compensate for thelack of light emitting from the meeting point of panels. The narrowerpanels 10 b, 10 d are also preferably operated at a higher power leveland/or at a higher emitted light intensity compared to the wider panels10 a, 10 c, 10 e in order to provide additional fill-in light.Furthermore, individual power regulation may aid in compensating formanufacturing variance that can occur in individual diodes. Finally, byfine-tuning each array 60, the panels can be easily deployed for otherapplications as each array is specifically configurable to address thelighting needs of the specific application.

The illuminator may further include a timer, which can indicate to theuser the appropriate length of exposure time for the particulartreatment. The illuminator may also be programmed with pre-stored lightdosing parameters to allow the user to select a desired treatment type.The pre-stored parameters may include, for example, pre-stored settingsfor exposure time, light intensity, and outputted wavelength. Based onthe selected treatment, the illuminator is automatically configured toprovide the correct lighting dosage by being supplied with theappropriate power output to achieve the required uniformity for thetreatment. Alternatively, the illuminator can be provided with sensorsthat detect the size of the treatment area positioned in front of theilluminator. The sensors then determine the correct light dosingparameters based on the sensed treatment area. The illuminator may alsofurther include actuators and may be programmed to be movedautomatically depending on the selected treatment. Once a treatment isselected, the illuminator may be automatically positioned into theproper configuration by the actuators without requiring the user to movethe system by hand. Alternatively, the sensors may detect the adjustedposition of the illuminator manually set by the user. The detectedposition of the illuminator may then be used to indicate the intendedtreatment area. Correct light dosing parameters for the specifictreatment area may then be provided based on the detected position setby the user.

The adjustable illuminator of the present invention allows for aninfinite amount of configurations that can be adapted for the targetedtreatment area. The configurations may range from a flat-plane emitter(as shown in FIGS. 1B and 2B) to a substantially U-shaped configuration(as shown in FIGS. 1A and 2A). The adjustable illuminator may also beconfigured such that the two end panels 10 a, 10 e can be pulled backrelative to the three middle panels 10 b, 10 c, 10 d, such that asmaller U-shaped configuration may be created by the middle panels.Thus, the adjustable illuminator allows for the treatment of additionalareas of a patient's body. In other words, not only can the adjustableilluminator effectively deliver a uniform light intensity to traditionalsurfaces such as the face or scalp, but the adjustable illuminator canalso provide a device that can easily be configured to treat otherportions of a patient's body, in particular, those having smaller curvedsurfaces, such as the arms and legs. Moreover, the adjustableilluminator may also be easily positioned to deliver a uniform lightintensity to larger treatment areas, such as the back or chest.

As described above, the narrower panels 10 b, 10 d are dimensioned suchthat the panels act as “lighted hinges.” Thus, when the wider panels 10a, 10 c, 10 e are adjusted into the desired form, the illuminator“bends” at the narrower panels 10 b, 10 d, where traditionally the“bend” would occur substantially at the hinge itself. Thus, instead ofan unlighted “bent” portion as would occur in the conventionalilluminator, the present illuminator provides a “bent” portion that isalso configured to emit light, thereby helping to reduce optical deadspace without requiring large amounts of power differentiation among thelight sources of each panel to provide the required fill-in light. Theeffects of this configuration can be best seen in a comparison of FIGS.7 and 8. FIG. 7 illustrates the light uniformity produced by aconventional illuminator, measured with a cosine response detector,which mimics the response of a patient's skin to the incident of lightas described above, at a distance of two inches. Total light dose, interms of J/cm², was measured based on emitted irradiance (W/cm²) overtime (in seconds). The targeted treatment area shown is a patient'shead, where height is shown as the y-axis and rotation angle from thecenter of the emitting surface is shown as the x-axis. As can be seen inFIG. 7, higher light doses of about 10 J/cm² occur at the center of theface (for example, at region A), near the patient's nose, where thepatient is facing closest to, and substantially perpendicular to, themiddle-most panel. Total light dose then begins to drop as movement awayfrom the center of the face occurs where the effects of cosine“fall-off” and optical dead spaces are more prevalent. For example,light dose is reduced by about 20% at the patient's cheek areas (forexample, at region B), and by about 80% toward the outer boundaries ofthe patient's face (for example, at region E), such as the ears andforehead. Thus, as shown in FIG. 7, conventional adjustable illuminatorsutilizing equally-sized panels operating at the same power output levelproduce a varying field of light uniformity, making it undesirable andineffective for those treatments requiring highly specific lightuniformity.

FIG. 8, on the other hand, illustrates the light uniformity produced byan embodiment of the present invention. The targeted treatment area isthe same as that measured in FIG. 7. However, compared to FIG. 7, thelight output uniformity produced by the illuminator is greatly enhancedacross the patient's face and exhibits little to no deviation from thelight output measured in the center of the patient's face to the lightoutput measured at the edges of the patient's face. For example, asshown in FIG. 8, total light doses of about 10 J/cm² (for example, atregion A′) occur across all regions of the face, including the center ofthe face (for example, the patient's nose), the patient's check areas,and the outer boundaries of the patient's cheek areas, such as the earsand forehead. Moreover, total light dose drops off minimally (forexample, at region B′) at the extreme outer boundaries of the patient'sface. In one embodiment, the measured output over the active emittingarea (over the entire active emitting area) is within 60% of themeasured maximum (over the entire active emitting area) measured with acosine response detector over all operation distances. More preferably,the measured output over the emitting area is within 70% of the measuredmaximum over a distance of two and four inches. Even more preferably,the measured output over the emitting area is within 80% of the measuredmaximum over a distance of two and four inches.

One example of a treatment method for precancerous lesions, such asactinic keratosis, by PDT utilizing an adjustable illuminator describedabove in conjunction with ALA will now be described.

Essentially anhydrous ALA is admixed with a liquid diluent just prior toits use. The ALA admixture is topically applied to the lesions using apoint applicator to control dispersion of the ALA admixture. After theinitial application of the ALA admixture has dried, one or moresubsequent applications may be similarly applied. Approximately 2 mg/cm²of ALA is administered. Formation of photosensitive porphyrin andphotosensitization of the treated lesions occurs over the next 14-18hours, during which time exposure to direct sunlight or other brightlight sources should be minimized. Between 14 and 18 hours afteradministration of the ALA, the lesions are irradiated by the adjustableilluminator according to the present invention. The illuminatorirradiates the lesions with a uniform blue light for a prescribedperiod. According to a preferred treatment, the visible light has anominal wavelength of 417 nm. The illuminator may irradiate the lesionswith a uniform red light for a prescribed period. In certainembodiments, the illuminator irradiates the lesions with a uniform bluelight for a first prescribed period and then irradiates the lesions witha uniform red light for a second prescribed period. For example, in someembodiments, the illuminator is configured to irradiate the lesions witha uniform blue light (e.g., 417 nm) at a low intensity (e.g., about 0.1J/cm² to about 2 J/cm²) to photobleach, for example, protoporphyrin IX(PpIX) present at the surface of the patient's skin, and irradiate thelesions with a uniform red light (e.g., 635 nm) at a high intensity(e.g., about 30 J/cm² to about 150 J/cm²) to activate PpIX present atdeeper layers of the patient's skin, thus avoiding potential damage tothe upper layers of the patient's skin. The illuminator may beconfigured to simultaneously irradiate the patient's skin with the lowintensity blue light and the high intensity red light or sequentiallyirradiate the patient's skin with the low intensity blue light and thehigh intensity red light. In certain embodiments, the illuminator isconfigured to irradiate the patient's skin with the low intensity bluelight for about one hour to about three hours and irradiate thepatient's skin with the high intensity red light for about 20 minutes toabout 30 or 40 minutes, either at the same time the patient's skin isirradiated with the low intensity blue light or after the patient's skinhas been irradiated with the low intensity blue light.

The invention thus provides a method for photodynamically diagnosing ortreating a contoured surface of a patient, which includes providing theadjustable illuminator described above, placing the patient in theilluminator, and illuminating the patient to diagnose or treat thepatient. The patient may be illuminated to treat actinic keratosis,acne, photo-damaged skin, cancer, warts, psoriasis, or otherdermatological conditions. The method may also be used to remove hairand diagnose cancer.

Since the total light dose (J/cm²) is equal to irradiance (W/cm²)multiplied by time (sec), the only additional parameter that needs to becontrolled for delivery of the correct treatment light dose is exposuretime. This may be accomplished by the timer described above, which cancontrol the electrical power supplied to the LED arrays 60appropriately, and which can be set by the physician. Data has shownthat 10 J/cm² delivered from a source with an irradiance density of 10mW/cm², or an irradiance density of about 9.3 to about 10.7 mW/cm²,produces clinically acceptable results for desired treatment areas(e.g., face, scalp, extremities). From the equation above, this lightdose will require an exposure time of 1000 seconds (16 min. 40 sec). Inaddition, due to the addressable nature of the adjustable illuminator,the illuminator may be used to treat a patient at higher power such thatless time is required for effective treatment. For example, theadjustable illuminator may deliver an irradiance density of 20 mW/cm²for an exposure time of 500 seconds (8 min. 20 sec) to deliver aclinically acceptable light dose of 10 J/cm². Alternatively, theadjustable illuminator may include higher power ranges, such as 30mW/cm², over an exposure time resulting in a light dose of 10 J/cm². Aselected light dose may also be administered by additionally oralternatively varying the irradiance density over treatment time.

Additional advantages and modifications will readily occur to thoseskilled in the art. Therefore, the invention in its broader aspects isnot limited to the specific details and representative devices andmethods, shown and described herein. Accordingly, various modificationsmay be made without departing from the spirit and scope of the generalinventive concept as defined by the appended claims and theirequivalents.

What is claimed is:
 1. A method, comprising: administering5-aminolevulinic acid (ALA) to a patient; positioning an illuminatorproximate to the patient, the illuminator comprising at least fivepanels, each of the panels comprising at least one light source, the atleast five panels connected by a plurality of hinges on inner sidesurfaces of adjacent panels that connect panels together such thatjoints of the hinges are substantially flush with front surfaces ofadjacent panels; and illuminating a surface of the patient with theilluminator, wherein the at least five panels comprise a first panelbetween two panels that are greater in width than the first panel.
 2. Amethod as set forth in claim 1, wherein the surface of the patientincludes a surface affected by actinic keratosis.
 3. A method as setforth in claim 1, wherein the surface of the patient includes a surfaceaffected by acne.
 4. A method as set forth in claim 1, wherein thepanels are configurable in a U shape or in a substantially flat shape.5. A method as set forth in claim 1, wherein outermost panels areconfigurable to be substantially parallel.
 6. The method of claim 1,wherein illuminating the surface comprises emitting light having awavelength from 400 nanometers to 430 nanometers.
 7. The method of claim1, wherein administering ALA to the patient comprises topically applyingALA.
 8. The method as set forth in claim 1, wherein the surface of thepatient includes a surface affected by cancer.
 9. A method, comprising:administering 5-aminolevulinic acid (ALA) to a patient; positioning anilluminator proximate to the patient, the illuminator comprising atleast five panels, each of the panels comprising at least one lightsource, the five panels comprising three panels having a first width andtwo panels that are narrower in width than the three panels having thefirst width; and illuminating a surface of the patient with theilluminator.
 10. A method, comprising: administering 5-aminolevulinicacid (ALA) to a patient; positioning an illuminator proximate to thepatient, the illuminator comprising at least five panels, each of thepanels comprising at least one light source, wherein the panels comprisefirst panels having a first width and at least one second panel having asecond width narrower than the first width, the panels being connectedby hinges disposed to reduce optical dead space between the panels; andilluminating skin of the patient with the illuminator.
 11. The method ofclaim 10, further comprising selectively controlling the light sourcesto increase intensity of light from light sources from at least oneportion of the illuminator to be greater than that from another portionof the illuminator to compensate for optical fall-off.
 12. The method ofclaim 10, further comprising selectively controlling at least one ofpower output to or light intensity of the light sources from a portionof the illuminator to increase the at least one of power output to orlight intensity of light sources closest to hinges to be greater thanthat from another portion of the illuminator.
 13. The method of claim10, further comprising controlling the at least one second panel havingthe second width to operate at a higher power level and/or a higherlight intensity than at least one of the first panels having the firstwidth.
 14. The method of claim 10, further comprising regulating poweroutput to individual panels of the illuminator.
 15. The method of claim10, further comprising controlling the illumination based on one or moreof an exposure time, light intensity, or outputted wavelength.
 16. Amethod, comprising: administering 5-aminolevulinic acid (ALA) to apatient; positioning an illuminator proximate to the patient, theilluminator comprising at least five panels, each of the panelscomprising at least one light source, the at least five panels connectedby a plurality of hinges on inner side surfaces of adjacent panels thatconnect panels together, at least one of the inner side surfaces havinga recess to accommodate therein at least part of one of the hinges; andilluminating a surface of the patient with the illuminator, wherein theat least five panels comprise two panels having a first width and threepanels greater in width than the two panels having the first widtharranged alternatingly.
 17. A method as set forth in claim 16, whereinthe part comprises a flange.
 18. A method as set forth in claim 16,wherein the part comprises a hinge joint.